# FDA recall Z-3045-2020

> **Ameditech Inc** · Class II · device recall initiated 2020-08-18.

## Product

ToxCup Drug Screen Cup (AMT Item Number/ AMT Description):      HT29A/"ToxCup¿ Drug Screen Cup  COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100  Adulteration Screen for CR - NI - PH - BL - S.G.",      DT14/ "ToxCup¿ Drug Screen Cup  THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300",    HT15/ "ToxCup¿ Drug Screen Cup  AMP1000/COC300/MET500/PCP25/ THC50/OPI2000",    HT15A/ ToxCup¿ Drug Screen Cup  AMP1000/COC300/MET500/PCP25/ THC50/OPI2000  Adulteration Screen for CR - NI - PH - BL - S.G.",     PT15/ "ToxCup¿ Drug Screen Cup  AMP1000/COC300/MET500/OPI300/THC50"    DT13A/ "ToxCup¿ Drug Screen Cup  THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100   w/  Cr, Ni, pH, BI, S.G.",     DT14A	"ToxCup¿ Drug Screen Cup  THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300  w/  Cr, Ni, pH, Bl, S.G. Finished Devices",    DT12A/"ToxCup¿ Drug Screen Cup  THC5

## Reason for recall

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

## Distribution

US - Nationwide  OUS - Australia, France, Germany, New Zealand, Singapore and Spain

## Key facts

- **Recall number:** Z-3045-2020
- **Recalling firm:** Ameditech Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-18
- **Report date:** 2020-10-07
- **Termination date:** 2024-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3045-2020

## Citation

> AI Analytics. FDA recall Z-3045-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3045-2020. Source: US FDA. Licensed CC0.

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